MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. FLUIDAIRII

Model Number 300680

Device Problems Device Inoperable (1663); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2014

Event Type  malfunction  

Event Description

It was initially claimed that the fluidair ii was leaking beads, which were going all over the room and into pt mouth.It has been established that no injury occurred as a result of this event; however, if it were to reoccur it may contribute or cause a serious injury, depending on the condition of the pt and/or other circumstances.

Manufacturer Narrative

(b)(4).As a consequence of issues with the integration of the former (b)(4) rental business into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of the complaint being old we have limited info on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations and implement corrections and corrective actions.Additional info will be provided upon conclusion of the investigation.

• Brand Name: FLUIDAIRII
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247 000
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4663598
• MDR Text Key: 5683396
• Report Number: 3009988881-2015-00019
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 300680
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other